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This is an opene-label, single center, randomized prospective pilot study to compare the efficacy of weekly versus triweekly fosaprepitant regimens for the prevention of nausea and emesis during concurrent chemoradiotherapy for nasopharyngeal carcinoma (NPC).
Scheme:
Eligible fosaprepitant sensitive (complete response [defined as no emesis and no use of rescue antiemetics] during the overall phase [0 to 120 hours] of all cycles of cisplatin-based induction chemotherapy) NPC patients will be randomized to 2 arms at 1:1 ratio.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weekly Arm | Experimental | fosaprepitant 150mg/m2 weekly in concurrent with radiotherapy during concurrent chemoradiotherapy |
|
| Triweekly Arm | Active Comparator | fosaprepitant 150mg/m2 triweekly in concurrent with chemotherapy during concurrent chemoradiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fosaprepitant | Drug | fosaprepitant 150mg/m2 weekly or triweekly during concurrent chemoradiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| the proportion of subjects with complete response (CR) overall | defined as no emesis and no use of rescue therapy | 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| the proportion of subjects with complete control (CC) overall | defined as no emesis and no use of rescue therapy and no significant nausea | 7 weeks |
| the proportion of subjects with sustained no emesis overall |
| Measure | Description | Time Frame |
|---|---|---|
| Progress-free survival (PFS) | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ming-Yuan Chen, MD,PhD | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37498596 | Derived | Yang Q, Zou X, Xie YL, Lin C, Ouyang YF, Liu YL, Duan CY, You R, Liu YP, Liu RZ, Huang PY, Guo L, Hua YJ, Chen MY. Fosaprepitant Weekly vs Every 3 Weeks for the Prevention of Concurrent Chemoradiotherapy-Induced Nausea and Vomiting: A Pilot Randomized Clinical Trial. JAMA Netw Open. 2023 Jul 3;6(7):e2326127. doi: 10.1001/jamanetworkopen.2023.26127. |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C579707 | fosaprepitant |
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| 7 weeks |
| the proportion of subjects with no nausea overall | 7 weeks |
| the proportion of subjects with no significant nausea overall | defined as no or mild nausea | 7 weeks |
| the proportion of subjects with CR in the 24 hours following initiation of radiotherapy and concomitant cisplatin | defined as no emesis and no use of rescue therapy | 24 hours |
| the proportion of subjects with CR in the 120 hours following initiation of radiotherapy and concomitant cisplatin | defined as no emesis and no use of rescue therapy | 120 hours |
| the mean time to first emetic episode | 7 weeks |
| Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) overall | 7 weeks |
| Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35) overall | 7 weeks |
| D009303 |
| Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |